Specialist, Regulatory Affairs Job in Baxter International

Summary: Under general supervision responsible for monitoring regulations and guidance for assigned submission types and coordinating and preparing standard submissions (i.e. US Drug Annual Reports) on behalf of Global Regulatory Leads. Essential Duties and Responsibilities: Prepare and compile assigned standard submissions on behalf of Global Regulatory Lead within timelines required by health authority Maintain awareness of regulatory requirements and ensure continued learning Maintain regulatory files in a format consistent with requirements Participate as an active team member of project teams as required Edit and proofread regulatory documentation Track status and progress of regulatory documentation Assist in preparation, review and maintenance of role-based deliverables Participate in other projects as assigned Qualifications: Knowledge of regulations Scientific knowledge Administrative and project management skills Ability to contribute to multiple projects from a regulatory affairs perspective Ability to multitask and prioritize Interpersonal and communication skills Technical system skills (e.g. word processing, spreadsheets, databases, online research) Proofreading and editing skills Education and/or Experience: Bachelor's degree or country equivalent in relevant scientific discipline. Suitable candidates with a non-scientific degree may be accepted and undertake further training. Regulatory experience (not mandatory) preferably within a healthcare environment